Status:
COMPLETED
Pilot Study of Bumetanide for Newborn Seizures
Lead Sponsor:
Soul, Janet , M.D.
Collaborating Sponsors:
Citizens United for Research in Epilepsy
Harvard Catalyst- Harvard Clinical and Translational Science Center
Conditions:
Seizures
Eligibility:
All Genders
Up to 44 years
Phase:
PHASE1
Brief Summary
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepilept...
Detailed Description
Seizures occur more often during the newborn period (2-3.5 per 1000 live births) than at any later age. Neonatal seizures can lead to frequent and serious long-term consequences in survivors, such as ...
Eligibility Criteria
Inclusion
- newborns with a post-conceptional age of 33-44 weeks
- condition with risk for seizure:
- asphyxia
- intracranial hemorrhage
- suspected or confirmed stroke
- CNS infection
- genetic syndrome
- focal or diffuse brain malformation
- idiopathic or presumed genetic etiology of seizures
- metabolic disorder other than electrolyte disturbances or those caused by renal failure
- suspected clinical seizure
Exclusion
- have transient metabolic abnormalities (e.g., transient hypocalcemia) as the sole cause of seizures
- are receiving ECMO (extracorporeal membrane oxygenation) therapy because of alteration of bumetanide pharmacokinetics by ECMO
- have contraindications to bumetanide (as determined by treating physician)
- have received diuretics such as furosemide or BTN
- newborns with a total serum bilirubin \> 15 mg/dL at enrollment
- newborns given ≥ 40mg/kg of phenobarbital
- loading doses of AEDs other than phenobarbital (those who receive levetiracetam are still eligible since levetiracetam does not affect bumetanide pharmacokinetics)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00830531
Start Date
January 1 2010
End Date
January 1 2019
Last Update
December 17 2020
Active Locations (4)
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1
Tufts Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115